Samarate, N/A, Italy
Quanta System, S.p.A. recalls
1 recall recorded since 2018, most recently on 27 April 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 27 April 2021
- Terminated
- 5 September 2023
- Reason
- Product sterility is potentially compromised.
- Distribution
- Nationwide distribution via 6 US distributors
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1844-2021, Z-1842-2021, Z-1843-2021
- Quanta System Sterile Optical Laser Fiber, reusable
- Olympus Sterile Optical Laser Fiber, single use and reusable
- Quanta System Sterile Optical Laser Fiber, single use
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.